|Mar 22, 2012
By: Amy Ritter
EPT–THE ELECTRONIC NEWSLETTER OF PHARMACEUTICAL TECHNOLOGY
Teva Pharmaceuticals received a Warning Letter from FDA informing the company that promotional materials as well as an associated webpage for Copaxone (glatiramer acetate injection) solution for subcutaneous injection were found to be false and misleading. Copaxone is indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS). FDA found that the materials overstated the efficacy, presented unsubstantiated claims, broadened the indication for Copaxone, and omitted and minimized important risk information associated with the drug.
FDA objected to wording in the promotional materials indicating that Copaxone’s safety record extended for 15–20 years, while the clinical-trials data in the FDA submission are only three years in duration. According to FDA, the open-label extension trials upon which the company based its claims are not sufficient to support those claims.
The promotional materials also included case studies from patients purportedly showing dramatic improvement in mobility and quality of life after taking Copaxone. According to the Warning Letter, the patient narratives misleadingly broaden the indication and overstate the efficacy of Copaxone by implying that Copaxone reverses patients’ disability and enables them to lead an active lifestyle, return to work, accomplish great athletic feats, and “live the life they’ve dreamed.” FDA says that while the patient narratives may be true reflections of those individual’s experiences, Copaxone is not indicated for slowing, preventing, or reversing physical disability associated with MS.
FDA also found that risk information was minimized or omitted in the promotional materials. In addition, the materials implied that Copaxone was safer than other treatments because it was not associated with risks associated with other drugs, when, in fact, those risks were associated with Copaxone. In the letter, FDA says it is not aware of adequate and well-controlled head-to-head clinical trials demonstrating that Copaxone is safer, more effective than, or otherwise superior to, other RRMS therapies.
The Office of Prescription Drug Promotion requested that Teva discontinue dissemination of violative materials and submit a plan to disseminate truthful, nonmisleading, and complete corrective messages about the issues discussed in the letter to those who received the violative promotional materials.